The approval expands treatment options for pediatric patients aged 1 year and above with chronic ITP who have not responded to other therapies.
Two formulations have been approved including once-daily tablet and oral suspension formulation designed for younger children who will find difficulty in swallowing tablets.
The approval was based on data from two clinical trials, under which patients in the treatment and placebo arms were allowed to use various stable maintenance ITP therapies.
Novartis said treatment with Revolade significantly increased and sustained platelet counts in pediatric patients with chronic ITP who were refractory to or had relapsed after prior chronic ITP therapies.
In addition, some patients who took concomitant ITP medications were able to reduce or discontinue their use of the medications, primarily corticosteroids.
Revolade is a once-daily oral thrombopoietin receptor agonist that works by inducing stimulation and differentiation of megakaryocytes from bone marrow stem cells to increase platelet production.
In August last year, the US Food and Drug Administration approved a new oral suspension formulation, expanding use of eltrombopag to include children 1 year of age and older with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
Revolade is approved in over 100 countries globally to treat thrombocytopenia in adult patients with chronic ITP who have had an inadequate response or are intolerant to other treatments.
Image: Novartis headquarters in Basel. Photo: courtesy of –Andrew- from Flickr.